510(k) · Cleared
ClearedD-LUX+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaDent Group International · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Aug 7, 2020 as substantially equivalent to K190272 (Ivoclar Vivadent, AG, 2019) after a 133-day review. Its family tree reaches back 3 generations to 2009. 7 later devices descend from it.
- Decided
- Aug 7, 2020
- Review
- 133 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K091020 (2009). 7 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK091020 Bluephase 20IIvoclar Vivadent, Inc. · 2009
- 2 generations backK163613 Bluephase Style 20iIvoclar Vivadent, AG · 2017
- 1 generation backK190272 Bluephase PowerCureIvoclar Vivadent, AG · 2019
- This deviceK200809 D-LUX+DiaDent Group International · 2020
- Descendant · cites it directly · 2 of its ownK220826 LED Curing LightFoshan Coxo Medical Instrument Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK221152 CuringPen Dental Curing LightChangzhou Sifary Medical Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK253131 Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK242386 BluemoonGenoss Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243921 LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K220826LED Curing LightFoshan Coxo Medical Instrument Co., Ltd. · 2022 · cites it directly2descendants
- K221152CuringPen Dental Curing LightChangzhou Sifary Medical Technology Co., Ltd. · 2022 · cites it directly1descendant
- K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd. · 2026 · 2 generations on0descendants
- K242386BluemoonGenoss Co., Ltd. · 2025 · cites it directly0descendants
- K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K091020 | Bluephase 20I | Ivoclar Vivadent, Inc. | 2009 | — |
| −2 | K163613 | Bluephase Style 20i | Ivoclar Vivadent, AG | 2017 | — |
| −1 | K190272 | Bluephase PowerCure | Ivoclar Vivadent, AG | 2019 | — |
| 0 (this device) | K200809 | D-LUX+ | DiaDent Group International | 2020 | — |
| +1 | K220826 | LED Curing Light | Foshan Coxo Medical Instrument Co., Ltd. | 2022 | — |
| +1 | K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | 2022 | — |
| +2 | K253131 | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | 2026 | — |
| +1 | K242386 | Bluemoon | Genoss Co., Ltd. | 2025 | — |
| +2 | K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EBZ device
- #1 K253131 Curing Light (M-Cure 6)score 12.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190272 | Bluephase PowerCureSummary page 4…ice Name: D-Lux+ 5.3 Predicate Devices The legally marketed devices to which substantial equivalence is being claimed are: 510(k) Number: K190272 (Primary predicate) Applicant: Ivoclar Vivadent, AG Device Name: Bluephase Powe… | 2019 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K220826 (Foshan Coxo Medical Instrument Co., Ltd., 2022) has gone furthest, with 2 descendants of its own.
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · EBZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBZ
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBZ
1in 2025
MAUDE reports naming product code EBZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 47 | 0 | 1 |
| 2008 | 5 | 75 | 0 | 7 |
| 2009 | 4 | 69 | 0 | 5 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 3 | 137 | 0 | 18 |
| 2012 | 1 | — | 1 | 20 |
| 2013 | 3 | 171 | 0 | 27 |
| 2014 | 3 | 289 | 0 | 31 |
| 2015 | 4 | 252 | 0 | 8 |
| 2016 | 4 | 251 | 0 | 3 |
| 2017 | 8 | 158 | 0 | 5 |
| 2018 | 2 | — | 1 | 3 |
| 2019 | 5 | 145 | 0 | 0 |
| 2020 | 5 | 164 | 0 | 2 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 5 | 144 | 1 | 5 |
| 2023 | 3 | 255 | 0 | 7 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 4 | 105 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The D-Lux+ is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515㎚ waveband of visible light.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200809: D-LUX+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200809
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026